Methods, Systems, and Products for Tracking Surgical Items

ABSTRACT

Methods, systems, and products track equipment used during surgical procedures. An allowable zone associated with a surgical procedure is identified. The allowable zone determines where surgical items may be used during the surgical procedure. A location of a surgical item is determined. When the location is outside the allowable zone, an alarm is triggered to indicate the surgical item is moving outside the allowable zone towards an area in which the surgical item may not be used.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.12/566,709, filed Sep. 25, 2009, and now issued as U.S. Pat. No. ______(Attorney Docket 060148 CON), which is a continuation of U.S.application Ser. No. 11/641,135, filed Dec. 19, 2006, and now issued asU.S. Pat. No. 7,617,137 (Attorney Docket 060148), with both applicationsincorporated herein by reference in their entirety.

BACKGROUND

The present invention relates generally to the use of radio frequencyidentification (RFID) devices, and more particularly, to systems andmethods used by these devices to support improvements in a surgicalsystem.

In a surgical suite it is important to keep track of all equipment usedduring an operation. Depending on the equipment being used, a typicaltracking method involves tracking items via manual counting by operatingpersonnel present in the suite. For example, this manual process couldinvolve counting surgical sponges in and then counting surgical spongesout upon completion of the operation. However, there are downsides tothis manual method. Mistakes can be made which can have both a hazardousoutcome for the patient and pose a significant financial loss for theresponsible institution. Additionally this recount method is timeconsuming and tedious. Accordingly, other methods have been developed toaddress this problem.

One such method used involves the use of a radiopaque. A radiopaque is amaterial that can be detected through the use of x-rays. Continuing withthe sponge example from above, a radiopaque thread is attached to asponge. Upon completion of the operation an x-ray device is used to scanthe patient. If the x-ray device detects a radiopaque thread, this mightmean that a sponge was left inside of the patient. While it is good thatthe sponge was found before the patient left the hospital, there arestill some significant cons to this method. For example, to retrieve thesponge, the patient may need to be re-operated upon. Another potentialproblem with using a radiopaque thread is that the thread could bedisposed behind a bone, which could hide the radiopaque thread from thex-ray device.

In addition to tracking surgical items to ensure the safety of thepatient, another important aspect of the surgical suite is management ofthe various medical processes associated with the people and equipmentas a whole. Keeping track of equipment, people, surgical tools anddisposable materials is a complex job. Therefore an efficient system formanaging the whole would be a useful improvement.

A basic Radio Frequency Identification (RFID) system typically includesan antenna (or equivalent), a transceiver and a transponder. RFID tagsare often attached to items for tracking purposes. These RFID devicescan come in a wide variety of sizes, and can contain a significantamount of data as desired. RFID tags, when coupled to equipment found ina surgical suite, provide a mechanism for resolving the problemsdescribed above and for improving practices in a surgical suite. RFIDtags have been disclosed for use in the surgical setting. For exampleU.S. Pat. No. 7,019,650 B2, the disclosure of which is incorporated hereby reference, describes an interrogator, a method of discerning metaland radio frequency identification (RFID) objects, and an interrogationsystem employing the same.

Exemplary embodiments described herein address the need for moreefficient systems and methods using RFID devices for both trackingsurgical equipment used during surgery and improving the whole surgicalsuite process using information available from RFID tags and otherdevices.

SUMMARY

According to one exemplary embodiment, a system for tracking surgicalitems includes a plurality of surgical items, wherein each item has anassociated RFID tag, a surgical table, wherein the surgical table has asensor capable of reading the RFID tags associated therewith, acomputing device in communication with the sensor, and a database incommunication with the computing device, wherein the computing deviceperforms at least one of the following functions based on informationreceived from the sensor and the database: (a) confirming a type ofsurgical procedure to be performed, (b) determining whether one or moreof the plurality of surgical items are located outside of at least oneallowable zone, the at least one allowable zone being determined basedon a type of surgical procedure to be performed, (c) determining whetherthe plurality of surgical items include a predetermined set of surgicalitems associated with the type of surgical procedure to be performed,(d) tracking disposable ones of the plurality of surgical items basedupon their usage during the surgical procedure, and (e) compilingbilling information associated with usage of the plurality of surgicalitems during the surgical procedure.

According to another exemplary embodiment, a method for tracking aplurality of surgical items includes the steps of providing a pluralityof surgical items, wherein each item has an associated RFID tag,interrogating the RFID tags to determine a location and identity of theplurality of surgical items, and performing at least one of thefollowing functions based on information received from the interrogatingstep: (a) confirming a type of surgical procedure to be performed, (b)determining whether one or more of the plurality of surgical items arelocated outside of at least one allowable zone, the at least oneallowable zone being determined based on the type of surgical procedureto be performed, (c) determining whether the plurality of surgical itemsinclude a predetermined set of surgical items associated with the typeof surgical procedure to be performed, (d) tracking disposable ones ofthe plurality of surgical items based upon their usage during thesurgical procedure, and (e) compiling billing information associatedwith usage of the plurality of surgical items during the surgicalprocedure.

According to yet another exemplary embodiment, a system for tracking aplurality of surgical items includes means for interrogating RFID tagsto determine a location and identity of a plurality of surgical items,and means for performing at least one of the following functions basedon information received from the interrogating means: (a) means forconfirming a type of surgical procedure to be performed; (b) means fordetermining whether one or more of the plurality of surgical items arelocated outside of at least one allowable zone, the at least oneallowable zone being determined based on the type of surgical procedureto be performed, (c) means for determining whether the plurality ofsurgical items include a predetermined set of surgical items associatedwith the type of surgical procedure to be performed, (d) means fortracking disposable ones of said plurality of surgical items based upontheir usage during the surgical procedure, and (e) means for compilingbilling information associated with usage of the plurality of surgicalitems during the surgical procedure.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings illustrate exemplary embodiments of thepresent invention, wherein:

FIG. 1 depicts a surgical suite according to exemplary embodiments;

FIG. 2( a) depicts a computing system in communication with a surgicaltable and an output device according to exemplary embodiments;

FIG. 2( b) illustrates an allowable zone according to exemplaryembodiments;

FIG. 3 is a flow chart illustrating an inventory management systemaccording to exemplary embodiments;

FIG. 4 is a flow chart illustrating an alert system according toexemplary embodiments;

FIG. 5 is a flow chart describing a method for tracking equipment usageaccording to exemplary embodiments;

FIG. 6 is a flow chart describing a billing system according toexemplary embodiments; and

FIG. 7 depicts a projected visual indicator which shows the location ofa tagged surgical item according to an exemplary embodiment.

DETAILED DESCRIPTION

The following detailed description of the invention refers to theaccompanying drawings. The same reference numbers in different drawingsidentify the same or similar elements. Also, the following detaileddescription does not limit the invention. Instead, the scope of theinvention is defined by the appended claims.

Radio frequency identification (RFID) systems typically include atransceiver and one or more transponders (RFID tags). The transceiveremits radio signals to activate the RFID tags and to read/write data tothem via an antenna. The transceiver typically has an associated decoderfor decoding data received from an RFID tag. The combination of anantenna, transceiver and decoder is sometimes referred to as an“interrogator” in an RFID system. The transponder can be electronicallyprogrammed with any desirable information, the constraint being size. Ina typical RFID system, the interrogator transmits radio waves (rangedependent upon power and frequency). When an RFID tag enters the zone inwhich the interrogator is transmitting, it detects the decoder'sactivation signal. This causes the RFID tag to transmit its data signalback to the interrogator. RFID tags can be active (i.e., have their ownpower source for generating the data signal) or passive (i.e., useelectromagnetic energy induced in the RFID tag by receipt of theactivation signal to generate the data signal). The decoder then decodesthe data on the RFID tag. This decoded data is then typicallytransmitted to a computing system that is in communication with thedecoder.

According to one exemplary embodiment of the present invention, asurgical table has the ability to query RFID devices that come withinits active zone. To provide a comprehensive system which facilitatessome of the work flow features described below, it may be useful for all(or substantially all) tools, equipment or materials (collectivelyreferred to herein as “surgical items”) used in the surgical process tohave an RFID tag either embedded within the tool, equipment or materialsor attached to the tool, equipment or materials. This method ofutilizing RFID tags improves the ability to track items in the surgicalsuite, particularly those items that come close to the patient. Anexample of a surgical suite according to an exemplary embodiment isdescribed with respect to FIG. 1. Therein, surgical table 102 has anattached or embedded sensor 104, e.g., an interrogator as describedabove, for interacting with RFID tags. Any item with an RFID tag thatcrosses boundary 106 towards surgical table 102 is noticed by sensor104. For example, upon tray 110 are surgical tools 112. These surgicaltools 112 each have an associated RFID device and, therefore, sensor 104“knows” where these devices are because these surgical tools 112 arewithin boundary 106 such that sensor 104 can transmit to, and receivefrom, the RFID tags associated with each of the surgical tools 112. Upontray 114 rest surgical tools 116. These surgical tools are not “known”by sensor 104 because surgical tools 116 are outside of boundary 106.However, to the extent that the range of the sensor(s) 104 associatedwith surgical table 102 is insufficient to encompass the entire areawithin which the devices, equipment and materials to be used in aparticular procedure, additional sensor(s) may be distributed about thesuite. Surgical table 102 is also in communication with a computingdevice 108. Computing device 108 and surgical table 102 shareinformation relating to the surgery and RFID tagged items.

According to another exemplary embodiment of the present invention, asurgical table is in communication with a computing device. Thissurgical table is equipped with a sensor(s) for reading RFID tags thatare attached to surgical equipment. The computing device is programmedwith information regarding the upcoming surgery such as type of surgery,location of surgery on the patient, potential tools/equipment to be usedduring the expected surgery and alarm zones. Exemplary uses of thissystem will be described with respect to FIGS. 2( a) and 2(b). Initiallythere is a surgical table 202, with an attached/embedded sensor 204 forinteracting with RFID tags, in communication with computing device 206.Computing device 206 contains information regarding the upcoming surgeryincluding, for example, patient identification information,identification of the procedure(s) to be performed and identification ofthe device(s), equipment(s) or material(s) to be used during theprocedure. Patient 208 can have an attached RFID tag (not shown) thatalso describes relevant information, such as the patient'sidentification and type of surgery to be performed. This RFID tag (notshown) is queried by sensor 204. The information gathered by sensor 204is then communicated to computing device 206. Computing device 206 thencompares the received data to the information it previously receivedrelating to the upcoming surgery. If the information does not match, analarm could be produced on or by output device 210 warning people in thesurgical suite not to proceed with the operation.

Assuming that the information matches, certain parameters related to theupcoming operation are created by computing device 206. For example,assuming that the upcoming operation is an appendix removal, thecomputing device could identify one or more allowable zones in whichcertain surgical tools may be used during the appendix removal procedure(or, conversely, zones in which surgical tools may not be used).Referring now to FIG. 2( b), an exemplary allowable zone 212 is depictedwith respect to patient 208. If a doctor were to move a surgical tooloutside of zone 212, towards a foot for example, an alarm would betriggered. This alarm could be audible, visual or both and displayed onor by output device 210 or on the surgical tool itself which has leftthe allowable zone. Similar to matching a patient 208 with data incomputing system 206, surgical tools (not shown) could be matched todata in computing system 206 and the presence of surgical tools whichare inappropriate for use in the surgical procedure which is next to beperformed in this particular surgical room or suite can be identifiedand brought to the attention of medical personnel, e.g., by way of adisplay 210 attached to computing device 206.

According to another exemplary embodiment of the present invention thereis a computing system that manages inventories of equipment before,during and after an operation. This computing system is in communicationwith both the surgical table and at least one output device. This systemcan work in tandem with the surgical suite described above, where eachpiece of disposable equipment has an attached RFID tag and the surgicaltable has a sensor to track RFID tagged equipment that enters itsinterrogation zone. This exemplary process will be described using theflow chart of FIG. 3. Initially a reorder point for a type of disposableitem used in an operation is created at step 302. Prior to beginning theoperation, the type of operation is verified and cross checked to ensurethat it matches with the next procedure previously programmed into thecomputer system at step 304. The surgical operation then begins, and asneeded, disposable items such as sponges, are used at step 306. Eachtime a disposable item is used, the computing system determines if theremaining inventory of the disposable item is at the reorder point step308. If the remaining inventory is above the reorder point nothingoccurs (except ongoing inventory tracking). If the remaining inventoryis at or below the reorder point, new inventory is automatically orderedat step 310 in the quantity already set up in the computing system.Ordering in this context can refer to local replenishment of thissurgical suite from a local storeroom, e.g., in a hospital, tohospital-wide replenishment of the local storeroom, or both. Thisprocess is repeated for each type of disposable item used in thesurgical process until the operation is complete.

According to another exemplary embodiment of the present invention, thespecific surgical tools used on a patient during an operation are linkedtogether and stored in a database. Tracking this information can beuseful because when a patient is determined to have a certain type ofcondition, such as a prion disease (Bovine Spongiform Encephalopathy),any surgical equipment that comes into contact with the patient during aprocedure is required to be taken out of service (destroyed). Aspreviously described a computing system is in communication with asurgical table and the surgical table is capable of reading the RFID tagof equipment used in the area. An exemplary method will be describedwith respect to the flowchart of FIG. 4. Initially all surgicalequipment has a RFID tag (step 402). An operation is performed upon apatient at step 404. A computing system receives the informationregarding the surgical equipment that was used during the operation fromthe surgical table. Pertinent information, such as information regardingpatient, operation, surgical equipment used and date, is linked togetherand saved in a database at step 406. Periodically, and prior to usingsurgical equipment in a new surgery, the system checks to determine ifan alert has been entered into the system at step 408. The alert can bemanually entered by a physician or nurse via a computing device or canbe automatically generated by the system based upon a surgical procedurebeing pre-categorized as requiring device, equipment or materialdestruction. An alert relates to the need to find and remove a set ofsurgical equipment from use for any reason, such as surgical equipmentused upon a patient with a prion disease. If no alert is found, the newoperation can begin. If an alert is found, the system determines if thesurgical equipment about to be used is linked to the patient associatedwith the alert at step 410. If there is no link between the surgicalequipment and the patient with the associated alert, the new operationcan begin. If there is a link between the surgical equipment and thepatient associated with the alert, appropriate personnel are notifiedand the surgical equipment is removed from service at step 412.Alternatively, anytime an alert is entered into the system, the systemcan immediately notify the appropriate personnel to go and remove theidentified surgical equipment from service.

According to another exemplary embodiment of the present inventionoperational usage of equipment in a surgical suite can be tracked usingRFID tags. This accurate method of tracking equipment operational usagewill allow for timely maintenance to be performed. A computing systemcan be provided in the surgical suite that is coupled to a sensorcapable of receiving RFID tag information from equipment in the surgicalsuite. An exemplary method for tracking equipment usage is shown in FIG.5 and described below. RFID tags are attached to all (or substantiallyall) surgical equipment, such as an electrocardiogram machine, in thesurgical suite for which the tracking of operating hours is desired atstep 502. Upon powering up a device for use, the device RFID transmits asignal at step 504. At step 506, this signal is received by thecomputing system and a start time is associated with the equipment thatgenerated the RF signal. At step 508, the device is powered off andanother RFID device transmits a signal. This signal is received by thecomputing system and an end time for the device is generated at step510. The computing system then sends the operational time to a databasewhich tracks usage hours by equipment at step 512. Finally, maintenancerequirements are updated as necessary in step 514. This exemplary methodallows equipment usage to be accurately tracked, which in turn allowspreventative maintenance to be performed at the times recommended by theequipment manufacturer or others. Additionally, it allows people to notuse equipment that has been operating for too long between maintenanceperiods. According to an alternative embodiment, instead of using RFIDtags to transmit separate signals when a device is turned on and when adevice is turned off, one RFID tag can be used to transmit continuouslywhile the device is powered up. Upon powering the device down, the RFsignal ceases, which is recognized by the computing system allowing thecomputing system to accurately log how many hours a device has been inan on condition.

According to another exemplary embodiment of the present invention, allequipment and personnel in a surgical suite during an operation can havea unique RFID tag associated with them. Combining this RFID taggingsystem with a method of checking items being used in and out of the zoneof usage provides the ability to count the hours of specific equipmentusage for billing purposes. This system is similar to the systemdescribed above for tracking equipment operational time for maintenancepurposes. An exemplary method for this billing tracking feature isdescribed below with respect to the flowchart in FIG. 6. Initially, atstep 602 all equipment (including disposable equipment) is equipped withan RFID tag. At step 604, all people entering the surgical suite have anRFID tag attached to them. These RFID tags are unique and can containpertinent information for billing, such as, a job function, piece ofequipment or a personnel identification/billing rate. Upon the start ofthe procedure, all people are checked in to the system. Additionally,equipment is checked in to the system when it is used or turned on foruse at step 606. Upon completion of the procedure, at step 608, thehours for each billable item is sent to a billing station. At step 610,an accurate bill for the procedure is created based upon the collectedhours and the rate for each person, piece of equipment and any otherdesired billing inputs.

According to another exemplary embodiment a surgeon's preferred tool setcan be tracked and readied for an upcoming operation. A surgeon'spreferred tool set can have an RFID tag attached to the container of thepreferred tools. Upon entering the surgical suite, both the tool set andthe surgeon can check into the system with their respective RFID tags.If the tool set matches the surgeon, the operation can proceed. If thetool set does not match the surgeon, a computing system can query adatabase to find the location of the tool set. The outcome of the querycan be displayed on an output device which then allows for someone toeither go and get the desired tool set or have another method ofdelivery occur.

In many of the exemplary embodiments described above, the surgical suitehas a computing system and/or a sensor for receiving RFID information.This method of communicating the RFID is only one of many methodspossible for capturing the desired information using RFID. Othervariations could be used by a person skilled in the art. For example,the use of computing systems, databases, and coupling methods forcommunicating between devices are well known in the art, as well as manyvariations of the same, such as, for example wireline or wirelesstransmission. Additionally, RFID tags can be either passive or activeand either method or both can be used in the exemplary embodimentsdescribed above with minor manipulation for a person skilled in the art.Moreover, the items which can be tagged with RFID tags according tothese exemplary embodiments can include any and all items which may beused in a surgical (or other medical) procedure, e.g., including drugsand medications. Further, systems in accordance with these exemplaryembodiments, can be combined with other monitored items or information(such as vital signs), to create a virtual reproduction of a givensurgery or other medical procedure, to track all of the items used andtheir location throughout the surgery event.

According to yet another exemplary embodiment of the present invention,the object location information obtained by the computing device 108from interrogating the RFID tags in a particular surgical suite can beused to provide feedback to the medical personnel performing a medicalprocedure therein. For example, a projector (not shown) can be connectedto the computing device 108 and attached, e.g., to a ceiling of thesurgical suite. The projector can be used to provide a visual indicationof the location of a requested object within the surgical suite. Forexample, if a doctor or nurse wants to know the location of a particularsponge (or all sponges) that are in the surgical suite, an appropriateinput can be made to the computing device 108 requesting that thelocation of that surgical sponge be pinpointed by the projector. Theprojector can then provide a visual indication of the precise locationof that surgical sponge. For example, as shown in FIG. 7, the projector(not shown) can project an icon 710 which shows the precise location ofa surgical sponge within patient 708 on surgical table 102. Thisfacilitates the subsequent procedure to remove the sponge.Alternatively, if the requested item or object is not located within thesurgical suite, the processor can emit an audible or visual alarm toalert the personnel that a requested object is not found. Inputs andoutputs to the computing device 108, e.g., to request the projector toprovide a visual indicator as described above, can be made using, e.g.,keyboard data entry or voice inputs.

Those skilled in the art will appreciate that the techniques describedabove in the foregoing exemplary embodiments can be applied in otherways to generate other exemplary embodiments. For example, from astructural point of view, the RFID sensors described above mayalternatively (or additionally) be provided within objects other than asurgical table, including (but not limited to) a portable handheld unit(e.g., wand), a container (e.g., trash can), other types of furniture(e.g., desk, chair), other apparatus (e.g., PDA, cellphone, etc.).Additionally, the various functions described above can be implementedseparately in both a physical and logical sense. For example, thebilling function described above can stand alone with respect to thescanning function, and vice versa.

The above-described exemplary embodiments are intended to beillustrative in all respects, rather than restrictive, of the presentinvention. Thus the present invention is capable of many variations indetailed implementation that can be derived from the descriptioncontained herein by a person skilled in the art. All such variations andmodifications are considered to be within the scope and spirit of thepresent invention as defined by the following claims. No element, act,or instruction used in the description of the present application shouldbe construed as critical or essential to the invention unless explicitlydescribed as such. Also, as used herein, the article “a” is intended toinclude one or more items.

1. A method, comprising: querying a database for a surgical procedure;identifying an allowable zone associated with the surgical procedure inwhich surgical items may be used; determining a location of a surgicalitem; determining the location is outside the allowable zone; andtriggering an alarm to indicate the surgical item is moving outside theallowable zone towards an area in which the surgical item may not beused.
 2. The method according to claim 1, further comprising associatingthe surgical procedure to a patient.
 3. The method according to claim 1,further comprising interrogating a tag to determine the location of thesurgical item.
 4. The method according to claim 1, further comprisingidentifying a zone in which the surgical item may not be used.
 5. Themethod according to claim 1, further comprising matching the surgicalitem to the surgical procedure.
 6. The method according to claim 5,further comprising producing the alarm when the surgical item does notmatch the surgical procedure.
 7. The method according to claim 1,further comprising billing for the surgical item used during thesurgical procedure.
 8. The method according to claim 1, furthercomprising determining an inventory of the surgical item.
 9. The methodaccording to claim 1, further comprising: comparing a remaininginventory of the surgical item to a reorder point; and when theremaining inventory is at or below the reorder point, ordering newinventory of the surgical item.
 10. A system, comprising: a processorexecuting a program that causes the processor to: query a database for asurgical procedure; identify an allowable zone associated with thesurgical procedure in which surgical items may be used; determine alocation of a surgical item; determine the location is outside theallowable zone; and trigger an alarm to indicate the surgical item ismoving outside the allowable zone towards an area in which the surgicalitem may not be used.
 11. The system according to claim 10, wherein theprogram further causes the processor to associate the surgical procedureto a patient.
 12. The system according to claim 11, wherein the programfurther causes the processor to produce the alarm when the surgicalprocedure does not match the patient.
 13. The system according to claim10, wherein the program further causes the processor to interrogate atag to determine the location of the surgical item.
 14. The systemaccording to claim 10, wherein the program further causes the processorto identify a zone in which the surgical item may not be used.
 15. Thesystem according to claim 10, wherein the program further causes theprocessor to match the surgical item to the surgical procedure.
 16. Thesystem according to claim 15, wherein the program further causes theprocessor to produce the alarm when the surgical item does not match thesurgical procedure.
 17. The system according to claim 10, wherein theprogram further causes the processor to bill for the surgical item usedduring the surgical procedure.
 18. The system according to claim 10,wherein the program further causes the processor to determine aninventory of the surgical item.
 19. The system according to claim 10,wherein the program further causes the processor to: compare a remaininginventory of the surgical item to a reorder point; and when theremaining inventory is at or below the reorder point, order newinventory of the surgical item.
 20. The system according to claim 10,wherein the program further causes the processor to track a time thesurgical item was used during the surgical procedure.